K042643 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II. This device is classified as a Albumin, Antigen, Antiserum, Control (Class II - Special Controls, product code DCF).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on November 18, 2004, 52 days after receiving the submission on September 27, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5040.
| 510(k) Number | K042643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2004 |
| Decision Date | November 18, 2004 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DCF — Albumin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5040 |